Roche Chemistry Analyzer 917 Class II

PRODUCT

Roche/Hitachi 917 Disk System Chemistry Analyzer, Catalog #917000.

Recall #Z-612-0.

REASON

There is a potential for mismatch of sample identification information
and results on all versions of software.

CODE

All units/software versions.

MANFACTURER/SOFTWARE SITE/SOFTWARE SITE:

Hitachi Instruments Division, Ibari-ken, 312 Japan.

RECALLED BY

Roche Diagnostics Corporation, Indianapolis, Indiana, by letter dated
March 17, 2000. Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

500 units were distributed.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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